Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma
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ClinicalTrials.gov Identifier: NCT00393796 |
Recruitment Status :
Terminated
(Low accrual)
First Posted : October 29, 2006
Results First Posted : November 13, 2014
Last Update Posted : November 13, 2014
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Condition or disease | Intervention/treatment | Phase |
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Bladder Cancer | Drug: SUTENT Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Randomized Blinded Phase II Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
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Active Comparator: SUTENT
Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
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Drug: SUTENT
50 mg/PO once daily for four consecutive weeks with a two week rest period. Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded. Participants receiving SU011248 will be removed from the study. Participants receiving placebo will be given the opportunity to "crossover" and receive SU011248.
Other Name: SU011248 |
Placebo Comparator: Placebo
Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
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Drug: SUTENT
50 mg/PO once daily for four consecutive weeks with a two week rest period. Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded. Participants receiving SU011248 will be removed from the study. Participants receiving placebo will be given the opportunity to "crossover" and receive SU011248.
Other Name: SU011248 Other: Placebo |
- Percentage of Participants That Experience Progression by 6 Months for Participants Receiving Sunitinib and Participants Receiving Placebo [ Time Frame: 6 Months Post Treatment ]
The primary endpoint of this unblinded, randomized trial is to compare the 6-month progression rate in patients randomized to maintenance SU011248 as compared with placebo following primary chemotherapy.
Progression is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologic/cytologic diagnosis of urothelial carcinoma (transitional cell carcinoma either pure or mixed histology)
- All patients must have received four - six cycles of standard first line chemotherapy (protocol details suggested combinations) for treatment of locally recurrent or metastatic disease AND must have achieved stable disease (SD), partial response (PR), or complete response (CR) to this chemotherapy.
- Type of response, number of cycles and specific regimen given must be carefully recorded and submitted at time of registration.
- Reports from pre and post treatment imaging will be required at time of registration to document response.
- Patients must be registered within 1 month (or the next business day if falls on a weekend or holiday) of scans demonstrating stable disease or better and no more than 42 days after receiving the last standard chemotherapy dose. For example, if patients are receiving treatment on days 1 and 8 of each cycle, day 8 of the last cycle would be considered the last standard chemotherapy dose.
- Patients may have received previous adjuvant or neoadjuvant therapy.
- No prior antiangiogenic therapy for this stage of the disease.
Exclusion Criteria:
- Major surgery within 4 weeks of starting the study treatment.
- NCI CTCAE grade 3 hemorrhage or higher within 4 weeks of starting the study treatment.
- History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases are allowed.
- Known HIV - positive patients may not participate. This is to avoid additional complications that immune suppression and HIV infection may cause due to the intense nature of the chemotherapy in this trial.
- Any of the following within 6 months prior to study administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Patients with history of or who are suspected to have CHF can be included as long as they are asymptomatic and have an ejection fraction that is equal to or above the institutional lower limit of normal by baseline MUGA(obtained within one month of registration or the next business day if falls on a weekend or holiday).
- Ongoing cardiac dysrhythmias of NCI CTCAE Grade > 2.
- Unresolved bacterial infection.
- Uncontrolled hypertension.
- Pre-existing thyroid abnormality that can not be controlled medically.
- Concurrent treatment on another clinical trial.
- Pregnant or breast-feeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393796
United States, California | |
David Geffen School of Medicine at UCLA | |
Los Angeles, California, United States, 90095 | |
United States, Illinois | |
The University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Minnesota | |
Mayo Clinic - Rochester | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Weill Medical College of Cornell University | |
New York, New York, United States, 10021 | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Principal Investigator: | Maha H. Hussain, M.D. | University of Michigan Rogel Cancer Center |
Responsible Party: | University of Michigan Rogel Cancer Center |
ClinicalTrials.gov Identifier: | NCT00393796 |
Obsolete Identifiers: | NCT01225848 |
Other Study ID Numbers: |
UMCC 2005.145 |
First Posted: | October 29, 2006 Key Record Dates |
Results First Posted: | November 13, 2014 |
Last Update Posted: | November 13, 2014 |
Last Verified: | November 2014 |
Carcinoma, Transitional Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Sunitinib Antineoplastic Agents Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |